Puncturable membrane for safety syringe

ABSTRACT

A safety syringe may define a variable fluid chamber and detached needle assembly. The variable fluid chamber may be hermetically sealed off from the environment or ambient air until the needle assembly is attached to a syringe body of the safety syringe. A proximal end of the variable fluid chamber is sealed off from the environment via a seal between a piston and syringe body. The distal end of the variable fluid chamber may be sealed off from the environment via a barrier covering the distal end of the syringe body. The barrier may be punctured to allow fluid to through tberethrough at or about the same time when the needle assembly is attached to the distal end portion of the syringe body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This applications claims the benefits of U.S. Provisional PatentApplication Ser. No. 60/857,088, the entire contents of which areincorporated herein by reference.

The entire contents of U.S. application Ser. No. 11/511,668, filed Aug.29, 2006 is expressly incorporated herein by reference. Additionally,the entire contents of U.S. Pat. No. 6,413,236, filed Jun. 20, 2000 toVan Dyke is expressly incorporated herein by reference. Also, the entirecontents of U.S. application Ser. No. 11/409,617, filed Apr. 24, 2006 isexpressly incorporated herein by reference.

STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT

Not Applicable

BACKGROUND

The present invention relates to a safety syringe wherein a variablefluid chamber is hermetically sealed off from contaminated ambient airuntil a needle assembly is attached to a syringe body such that fluidicmedication may be withdrawn from a medication vial and injected into apatient in a sterile manner.

FIG. 1 illustrates a conventional safety syringe with a detached needleassembly. During use, a medical professional may select the appropriatesized needle based on the fluidic medication to be administered to thepatient. Once the appropriate sized needle is selected, the needleassembly may be attached to the syringe body of the safety syringe.Unfortunately, a distal end of the syringe body is uncovered. As such,from the time that the syringe is removed from its packaging to the timethat the needle assembly is attached to the syringe body, ambient air isallowed to flow into a variable fluid chamber which houses the fluidicmedication right before the fluidic medication is injected into thepatient. The ambient air flowed into the variable fluid chamber maycontain viruses, bacteria or other unwanted contaminants which may helodged onto the inner surface of the variable fluid chamber. When thefluidic medication is withdrawn into the variable fluid chamber, thecontaminant lodged onto the inner surface of the variable fluid chambermay contaminate the fluidic medication to be injected into the patient.

Accordingly, there is a need in the art for a device and a method forinjecting fluidic medication into the patient in a sterile manner.

BRIEF SUMMARY

The safety syringe discussed herein addresses the needs discussed above,discussed below and those that are known in the art.

The safety syringe provides a sterile environment in which the fluidicmedication may be withdrawn from a medication container and subsequentlyinjected into the patient. More particularly, the safety syringe mayhave a barrier disposed at a distal end portion of a syringe body of thesyringe. The barrier provides an impermeable air barrier between theenvironment (contaminated ambient air)and the variable fluid chamber.The barrier may be punctured at or about the same time when a needleassembly is attached to the syringe body. When the barrier is punctured,the needle assembly then acts as a cover such that contaminated ambientair does not enter into the variable fluid chamber after the barrier ispunctured by the needle assembly. As such, at no time during the processof removing the syringe from its packaging, attaching the needleassembly to the syringe body, withdrawing fluidic medication from amedication container and injecting the patient with the fluidicmedication was the variable fluid chamber exposed or allowed to haveambient air flow therein. Hence, the fluidic medication injected intothe patient is performed in a sterile manner.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the various embodimentsdisclosed herein will be better understood with respect to the followingdescription and drawings, in which like numbers refer to like partsthroughout, and in which:

FIG. 1 is a perspective view of a prior art safety syringe;

FIG. 2 is a perspective view of a safety syringe with a barrier and adetached needle assembly which is attachable to the syringe body;

FIG. 3 is a front cross-sectional view of the safety syringe shown inFIG. 2;

FIG. 4 is an alternate embodiment. of attaching the harrier to thesyringe body;

FIG. 5 is a bottom view of the barrier illustrating score lines formingeight pie-shaped pieces wherein the score lines are depressions formedin the barrier to control tearing, ripping or weakening of the barrier;

FIG. 6 illustrates the pie shaped pieces shown in FIGS. 2 and 5 when thebarrier is punctured by the needle assembly;

FIG. 7 is a bottom view of the barrier illustrating an alternateconfiguration of the score lines;

FIG. 8 is a bottom view of the barrier illustrating the score lineshaving a wavy configuration; and

FIG. 9 is a front cross-sectional view of a safety syringe wherein thebarrier is attached to an inner surface of the syringe body.

DETAILED DESCRIPTION

Referring now to the drawings, FIG. 2 is a perspective view of a safetysyringe 10. In particular, the safety syringe 10 may comprise a plungerassembly 12 partially disposed within a syringe body 14. Fingerplatforms 16 may be attached to a proximal end of the syringe body 14 toassist the user in traversing the plunger assembly 12 between aretracted position and a forward position. The safety syringe 10 mayalso comprise a detached needle assembly 18 which may be attached to thesyringe body. One benefit of having the needle assembly 18 initiallydetached from the syringe body 14 and a selected needle assembly 18attachable to the syringe body is that a medical professional may attachan appropriately sized needle 20 to the syringe body 14 depending cm theparticular mediation to be administered to the patient.

The safety syringe 10 is directed to a device and a method formaintaining sterility of fluidic medication during the entire process ofwithdrawing fluid medication from a medication container and injectingthe fluidic medication to the patient. The safety syringe 10accomplishes this by providing a barrier 22 between the environmentwhich contains contaminated ambient air and a sterile variable fluidchamber 26.

In particular, the safety syringe 10 may be provided to a medicalprofessional. The needle assembly 18 may initially be detached from thesyringe body 14. Moreover, the plunger assembly 12 may be initiallypositioned in a retracted position when provided to the medicalprofessional. As used herein, a retracted position of the plungerassembly is where a piston 28 of the plunger assembly 12 is closer to aproximal end of the syringe body 14 compared to a distal end portion 30of the syringe body 14. When the safety syringe 10 is assembled by themanufacturer, the safety syringe 10 is also sterilized to kill oreliminate harmful or potentially harmful viruses, bacteria and otherunwanted contaminants that may be on or in the safety syringe 10. Moreparticularly, during the sterilization process, the inner surface of thevariable fluid chamber 26 is sterilized. In particular, the innersurface of the variable fluid chamber 26 may be defined by a distal end32 of the piston 28, an inner surface 34 of the syringe body 14 and aproximal surface 36 of the barrier 22.

In use, to administer a fluidic medication to a patient, the needleassembly 18 is attached to the distal end portion 30 of the syringe body14. At or about the same time, the barrier 22 is punctured to allowfluidic medication to be drawn into the variable fluid chamber 26 andsubsequently ejected out of the variable fluid chamber 26 and injectedinto the patient via the needle 20.

One of the many important aspects of the safety syringe 10 is that theinner surface of the variable fluid chamber 26 does not come intocontact with the contaminated ambient air 24 during the process ofattaching the needle assembly 18 to the syringe body 14. Before theneedle assembly 18 is attached to the syringe body 14, the barrier 22prevents contaminated ambient air 24 from entering into the variablefluid chamber 26. The barrier 22 is punctured to allow fluid and/or airto enter into or escape out of the variable fluid chamber 26 at or aboutthe same time that the needle assembly 18 is attached to the syringebody 14. At such time, the needle assembly 18 then behaves as a coverafter the barrier 22 is punctured such that ambient air does not enterinto the variable fluid chamber 26 and possibly contaminate the variablefluid chamber 26 due to airborne viruses, bacteria or unwantedcontaminants in the ambient air 24.

After the needle assembly 18 is attached to the syringe body 14, thefluidic medication may be withdrawn from a medication vial and beadministered to the patient. In particular, the needle 20 of the syringe10 may be inserted into a medication container or vial. At this time,the plunger assembly may be traversed toward the forward position. Theforward position is defined where the piston 28 is closer to the distalend portion 30 of the syringe body 14 compared to a proximal end of thesyringe body 14. As the plunger assembly 12 is traversed toward theforward position, sterilized air contained in the variable fluid chamber26 is transferred into the medication container. Such transfer ofsterilized air 38 increases the pressure within the medication containerto assist in withdrawal of the fluidic medication therefrom. Themedication container and safety syringe 10 may now be inverted such thatthe medication container is positioned over the safety syringe 10. Adistal tip 40 of the needle 20 may be positioned within the fluidicmedication contained in the medication container. Now the plungerassembly 12 may be traversed back toward the retracted position. Suchretraction of the plunger assembly 12 traverses the fluidic medicationcontained in the medication container into the variable fluid chamber 26of the safety syringe 10, As you will note, the fluidic medication inthe variable fluid chamber 26 was not exposed to ambient air 24. Themedical professional may remove the needle 20 from the medicationcontainer and remove any sterilized air 38 from within the variablefluid chamber by inverting the safety syringe 10, tapping on syringebody 14 to urge the sterilized air 38 toward the needle 20, and thenslightly traversing the plunger assembly 12 toward the forward positionto eject the sterilized air 38 and a negligible amount of the fluidicmedication out of the variable fluid chamber 26 and the needle assembly18. At this time, the medical professional may inject the patient withthe fluidic medication contained in the variable fluid chamber 26.

In an aspect of the safety syringe 10, the needle assembly 18 may beattachable to the to the syringe body 14 in a plurality of differentmethods known in the art, discussed herein and those that are developedin the future. By way of example and not limitation, as shown in FIG. 3,the needle assembly 18 may have threads 42 disposed at a proximal endportion 44 of the needle assembly 18. Mating threads 46 may be formed atthe distal end portion 30 of the syringe body 14. More particularly, themating threads 46 may he firmed on an inner surface 34 of the syringebody 14, whereas, the threads 42 of the needle assembly 18 may be formedon an outer surface of the proximal end portion 44 of the needleassembly 18. To attach the needle assembly 18 to the syringe body 14,the threads 42 may be threaded onto the mating threads 46. To lock theneedle assembly 18 onto the syringe body 14, the needle assembly 18 maybe formed with a stop flange 48. As the needle assembly 18 is threadedinto the syringe body 14, the stop flange 48 may eventually contact thedistal end portion 30 of the syringe body 14. The needle assembly 18 maythen be cinched or tightened onto the syringe body 14 to insurefrictional attachment between the needle assembly 18 and the syringebody 14. The above description of attaching the needle assembly 18 tothe syringe body 14 is one embodiment of attaching the needle assembly18 to the syringe body 14. The safety syringe 10 discussed herein shouldnot be limited only to this embodiment but also contemplates any othermethods and embodiments.

In an aspect of the safety syringe 10, various types of barriers 22 arccontemplated. By way of example and not limitation, as shown in FIG. 3,the barrier 22 may be an air impermeable membrane disposed over thedistal end portion 30 of the syringe body 14. The air impermeablemembrane may he hermetically sealed about the outer periphery of thedistal end portion 30 of the syringe body 14. Such seal is identified asreference numeral 50 in FIG. 3. The seal 50 may be formed via coldadhesive, hot adhesive, sonic welding as well as other methods known inthe art or developed in the future, The air impermeable membraneprevents non-sterile air of the environment from entering into thevariable fluid chamber 26 after the safety syringe 10 is removed fromits packaging and prior to mounting of the needle assembly 18 onto thesyringe body 14.

In another aspect of the safety syringe 10, as shown in FIG. 4, thebarrier 22 may be attached to the distal end 52 of the syringe body 14.Such attachment may be made by cold adhesive, hot adhesive, sonicwelding, as well as other methods that may be know in the art ordeveloped in the future. The seal between the barrier 22 or airimpermeable membrane and the distal end 52 of the syringe body 14 may beidentified as reference numeral 54 in FIG. 4.

In an aspect of the safety syringe 10, the puncturing of the barrier 22may be controlled. In particular, as shown in FIG. 2 and FIG. 5, thepuncturable barrier 22 may have a plurality of score lines 56. The scorelines urge the puncturable barrier 22 to tear or weaken at the scorelines 56 to permit fluid to pass through the barrier 22. The score lines56 may be depressions formed on a proximal or distal side of the barrier22. As shown in FIG. 6, when the needle assembly 18 (not shown in FIG.6) is attached to the syringe body 14, pie-shaped pieces 58 of theharrier 22 are pushed into the variable fluid chamber 26. The pie shapedpieces 58 are disposed between the threads 42 of the needle assembly 18and the mating threads 46 of the syringe body 14. Fluid (e.g., fluidicmedication) may now pass into or out of the variable fluid chamber 26.

Although the score lines 56 as shown in FIG. 5 are formed as in aplurality of pie-shaped pieces 58, other configurations of the scorelines 56 are contemplated. By way of example and not limitation, thescore lines 56 may be formed on the puncturable harrier 22 as shown inFIG. 7. FIG. 8 shows an alternative embodiment of a differentconfiguration of the score lines 56. As shown, each score line 56 mayhave a wavy pattern.

In an aspect of the barrier 22, the barrier 22 may be fabricated from anair impermeable material. By way of example and not limitation, theimpermeable material may be plastic, paper, rubber, cloth, etc. Thebarrier 22 may be perforated but still be characterized as impermeableso long as a free flow of ambient air is not allowed to pass through thebarrier 22 into the variable fluid chamber 26.

In another aspect of the safety syringe 10, as shown in FIG. 9, thebarrier 22 may extend across the inner periphery of the syringe body 14above the threads 42 of the mating threads 46 of the distal end portion30 of the syringe body 14. To mount the needle assembly 18 to thesyringe body 14, the threads 42 of the needle assembly 18 is threadedonto the mating threads 46. The needle assembly 18 is threaded into thesyringe body 14 until the stop flange 48 contacts the distal end 52 ofthe syringe body 14. At or about the same time, a protrusion 60 of theneedle assembly 18 may puncture the barrier 22. By way of example andnot limitation, the protrusion 60 may at least slightly tear or weakenthe barrier 22 to allow the fluidic medication to enter into or escapeout of the variable fluid chamber 26. The barrier 22 may becharacterized as punctured if the barrier 22 is torn or weakened so asto permit fluid to permeate through the barrier 22.

In an aspect of the safety syringe 10, the syringe 10 may be asterilized vacuum assisted retractable safety syringe as discussed inU.S. application Ser. No. 11/511,668 ('668 application), filed Aug. 29,2006, the entire content of which is incorporated herein by reference.The '688 application discusses how fluidic medication is injected intothe patient in a sterile manner if the needle assembly is attached tothe syringe body. In this regard, the discussion of the '668 applicationmay he employed in the safety syringe 10 with detached needle assemblydiscussed herein after the detached needle assembly 18 is attached tothe syringe body 14. Additionally, the safety syringe 10 may be a vacuumassisted retractable safety syringe as discussed in U.S. Pat. No. 6,413,236, filed Jun. 20, 2000 to Van Dyke, the entire content of which isincorporated herein by reference.

The safety syringe 10 may have a variable vacuum compartment 62 (seeFIG. 3). When the plunger assembly 12 is in the retracted position, thevariable vacuum compartment has a pressure equal to ambient pressure. Asthe plunger assembly 12 is traversed toward the forward position, thevariable vacuum compartment 62 increases in volume but additional airmolecules are not introduced into the variable vacuum compartment 62.The reason is that there is a seal between the piston 28 and the innersurface 34 of the syringe body 14 as well as a seal between a shaft 64and proximal end of the syringe body 14. One benefit of the vacuumassisted retractable safety syringe 10 is that the inner surface of thevariable fluid chamber 26 will not become contaminated by introductionof contaminants via the proximal end of the syringe body 14. Ambient airdoes not enter into the variable vacuum compartment 62 through theproximal end of the syringe body 14.

Although the variable vacuum compartment 62 and the variable fluidchamber 26 are separate compartments, during the process of injectingthe patient with fluidic medication via the safety syringe 10, thevariable fluid chamber 26 and the variable vacuum compartment 62 share acommon surface, namely, the inner surface 34 of the syringe body. Forexample, the plunger assembly 12 is traversed between two positions,namely, the retracted position and the forward position. When theplunger assembly 12 is in the retracted position, the variable fluidchamber 26 typically has a larger volume compared to the variable vacuumcompartment 62. When the plunger assembly 12 is traversed toward theforward position, the volume of the variable vacuum compartment 62increases and the volume of the variable fluid chamber 26 decreasesbecause the distal end 28 slides downward against the inner surface 34of the syringe body 14. Accordingly, a portion of the inner surface 34of the syringe body which used to define the variable fluid chamber 26now at least partially defines the variable vacuum compartment 62.

If ambient air 24 were to enter into the variable vacuum compartment 62via the proximal end of the syringe body 14, then contaminants containedin the ambient air 24 may be lodged onto the inner surface 34 of thesyringe body. As the plunger assembly 12 is traversed between theretracted position and the forward position, the lodged contaminants onthe inner surface 34 of the syringe body may eventually enter into thevariable fluid chamber and thereby contaminate any fluidic medicationdrawn into the variable fluid chamber 26.

A benefit of the vacuum assisted retractable safety syringe is that thevariable vacuum compartment 62 remains in a sterile state throughout theentire process of injecting the patient with fluidic medication becauseambient air is not allowed into the variable vacuum compartment 62 viathe proximal end of the syringe body 14.

Combining the vacuum assisted retractable safety syringe 10 with thebarrier 22 provides a complete sterile environment in which the fluidicmedication may be withdrawn into the variable fluid chamber 26 andsubsequently injected into the patient without concern that the fluidicmedication may become contaminated by exposure to the ambient air 24 orto contaminants that may have entered into the variable fluid chamber 26via the proximal end of the syringe body 14.

In an aspect of the syringe 10, the detached needle assembly 18 may beattachable to the syringe body 14, as discussed in U.S. application Ser.No. 11/409,617, filed Apr. 24, 2006, the entire contents of which areexpressly incorporated herein by reference. Additionally, the needle 20of the needle assembly 18 may be retractable into the syringe body 14 asshown in U.S. application Ser. No. 11/409,617. Moreover, the barrier 22may be attached to the distal end portion 30 of the syringe body 14shown in FIGS. 1-5 of U.S. application Ser. No. 11/409,617.

The above description is given by way of example, and not limitation.Given the above disclosure, one skilled in the art could devisevariations that are within the scope and spirit of the inventiondisclosed herein. Further, the various features of the embodimentsdisclosed herein can be used alone, or in varying combinations with eachother and are not intended to be limited to the specific combinationdescribed herein. Thus, the scope of the claims is not to be limited bythe illustrated embodiments.

1-12. (canceled)
 13. A syringe for injecting a patient with fluidicmedication in a sterile manner, the syringe comprising: a plungerassembly having a piston and a shaft; a syringe body having a proximalportion and a distal portion, the piston and shaft disposed within thesyringe body with the shaft extending out of the proximal portion of thebody, the piston being traversable between a refracted position and aforward position within the syringe body, the piston and syringe bodydefining a variable fluid chamber disposed on a distal side of thepiston with sterile gas disposed therein; a barrier disposed at thedistal portion of the syringe body, the barrier configured to preventair transfer between an environment and the variable fluid chamber andconfigured to maintain sterility of the variable fluid chamber; and aneedle disposed at the distal portion of the syringe body, wherein thebarrier is breakable to allow fluidic medication to flow into or out ofthe variable fluid chamber through the needle.
 14. The syringe of claim13, which includes a needle assembly including the needle, and whereinthe needle assembly is detachable to the distal portion of the syringebody.
 15. The syringe of claim 14, wherein a syringe end of the needleassembly is configured to puncture the barrier to allow the fluidicmedication to flow into or out of the variable fluid chamber through theneedle.
 16. The syringe of claim 13, wherein the piston and syringe bodyfurther define a variable vacuum chamber on a proximal side of thepiston, and wherein a proximal seal is disposed between the shaft andthe proximal portion of the syringe body to maintain sterility of thevariable vacuum chamber.
 17. The syringe of claim 13, wherein thebarrier is attached directly to the syringe body.
 18. The syringe ofclaim 13, wherein the barrier is disposed over a distal end of thedistal portion of the syringe body.
 19. The syringe of claim 13, whereinthe barrier is hermetically sealed about an outer periphery of thedistal portion of the syringe body.
 20. A syringe for injecting apatient with fluidic medication in a sterile manner, the syringecomprising: a plunger assembly having a piston and a shaft; a syringebody having a proximal portion and a distal portion, the piston andshaft disposed within the syringe body with the shaft extending out ofthe proximal portion of the body, the piston being traversable between arefracted position and a forward position within the syringe body, thepiston and syringe body defining a variable fluid chamber disposed on adistal side of the piston with sterile gas disposed therein; a barrierforming at least a portion of the variable fluid chamber, the barrierconfigured to prevent air transfer between an environment and thevariable fluid chamber and configured to maintain sterility of thevariable fluid chamber; and a needle disposed at the distal portion ofthe syringe body, wherein the barrier is breakable to allow fluidicmedication to flow into or out of the variable fluid chamber through theneedle.
 21. The syringe of claim 20, wherein the barrier is attacheddirectly to the syringe body.
 22. The syringe of claim 20, wherein thebarrier is disposed over a distal end of the distal portion of thesyringe body.
 23. The syringe of claim 20, wherein the barrier ishermetically sealed about an outer periphery of the distal portion ofthe syringe body.
 24. The syringe of claim 20, wherein the piston andsyringe body further define a variable vacuum chamber on a proximal sideof the piston, and wherein a proximal seal is disposed between the shaftand the proximal portion of the syringe body to maintain sterility ofthe variable vacuum chamber.
 25. A method of injecting a fluid, themethod comprising: receiving a syringe with a barrier configured toprevent air transfer between an environment and a variable fluid chamberlocated within a body of the syringe, the variable fluid chamberdisposed on a distal side of a piston, the piston being disposed in aretracted position within the syringe body and sterile gas disposedwithin the variable fluid chamber; puncturing the barrier so thatfluidic medication can flow into or out of the variable fluid chamberthrough a needle disposed at a distal portion of the syringe body;traversing the piston towards the distal portion of the syringe body totransfer the sterile gas out of the variable fluid chamber; positioningan opening of the needle within fluid in a container; traversing thepiston towards a proximal portion of the body to transfer the fluid inthe container into the variable fluid chamber; and injecting the personwith the fluid in the variable fluid chamber.
 26. The method of claim25, which includes attaching the needle to the distal end portion of thesyringe body.
 27. The method of claim 26, wherein puncturing the barrieris performed by attaching the needle to the distal portion of thesyringe body.
 28. The method of claim 25, wherein puncturing the barrierincludes rupturing the barrier along a plurality of score lines.
 29. Themethod of claim 25, which includes threading a syringe end of the needleto the distal portion of the syringe body.
 30. The method of claim 25,which includes inserting the needle into a container containing thefluid to be injected into a person.
 31. The method of claim 30, whereintraversing the piston towards the distal portion of the body includestransferring the sterile gas within the variable fluid chamber into thecontainer to pressurize the container and assist in subsequentwithdrawal of the fluid contained within the container.
 32. The methodof claim 25, which includes, simultaneously with the traversing step,enlarging a volume of a variable vacuum chamber which is disposed on aproximal side of the piston without the addition of environmental air toinduce a vacuum force on the piston toward the retracted position and tomaintain sterility of the variable vacuum chamber.